Data

The EU falsified medicines directive (FMD) is driving a fundamental shift in the way businesses throughout the pharmaceutical supply chain manage and communicate data. Implementing compliant serialisation strategies means extensive data management requirements that demand the generation and sharing of new types of data never previously managed by the industry.

Comprehensive and substantive master data management (MDM) strategies developed collaboratively with supply chain partners are a must if businesses want to meet the data security and integrity requirements associated with serialisation.

The complexity of introducing a serialisation solution has, to date, been largely underestimated. In the EU, many manufacturers and packaging organisations have simply been too slow to adopt processes that will ensure compliance ahead of the 2019 deadline.

The data journey

At the broadest level, under FMD requirements, manufacturers that supply products within the EU will have to report data about said products to the EU Hub, which will then route the appropriate data to the national repositories for each member state where it is accessed and used for verification at dispense. However there a few devils in the detail.

The first stage of the serialisation data journey involves the manufacturer or marketing authorisation holder (MAH) packaging and serialising the drug product. Master data (product codes, form, dosage, target market(s) for distribution, etc.) as well as the serialisation data has to be captured, transferred and stored internally. This process may involve working with internal sites, with CMOs, or in conjunction with 3PL distribution sites and this is where the first real challenge arises.

Upgrading packing lines and adding codes to packs is not a hugely difficult task but managing master data is challenging and becomes exponentially more difficult when compliance requires it to be communicated across a larger ecosystem. FMD compliance requires a system to synchronise information (in near to real time) across different markets; without it, companies must develop complex business logic to retrieve data for any required tasks from verification to reporting. This is time-consuming and ultimately wastes resources when compared to implementing and using an internal MDM strategy. Companies are now realising that integrating with supply chain partners is incredibly complicated. It’s the case across the industry that businesses are working with different vendors, working to different timescales and with different levels of resource. Creating a unified approach to data in this environment is a significant challenge.

Once the data is being effectively managed and communicated at the enterprise level, MAHs are then required to submit product master data and serialisation data to the EU Hub. Parallel importers/distributors (PI) must submit similar data into the EU Hub for the medicines they repackage or relabel. In order to do this, the MAHs and PIs must have established an account with the European Medicines Verification Organisation (EMVO) through its on-boarding process anddecided which legal entity will act as their On-boarding Partner (OBP), the entity certified by EMVO to upload serialisation data on behalf of affiliated MAHs. All relevant data is transferred via the OBP to the EMVO so it’s also important to determine how the OBP will receive information from its partners and then connect to and communicate with the EU Hub. OBPs in fact may use a third-party certified Gateway Provider to manage data from its internal and partner sites and transmit it to the EU Hub.

Stakeholders throughout the supply chain then need to be able to access this data, meaning that they are not only storing their own data, but transferring others’ data securely. Events such as recalls, withdrawals decommissioning and recommissioning will also have to be reported in a secure way in the required formats. Updating master data requires a system that can manage changes to information that may or may not have been generated within the owner’s organisation. This creates an integration requirement whereby third-parties can provide updates which feed into an automated process where the new master data is submitted and stored both internally and within the EU Hub. Having separate systems for each of these processes is more resource intensive and has the potential to cause serious problems in the future.

Implementing an MDM framework

Implementingan MDM framework is one of several essential steps a business can take towards meeting the challenges posed by serialisation while future-proofing itself against the constantly evolving requirements of data management.

An MDM structure is essentially made up of four core pillars:

1. A hub

The ideal hub holds all of the master data in an accessible repository. There are two types of MDM hubs, and the one a business adopts will depend on the systems and processes used to collate the data. In a ‘Persistent Hub’, critical data is simply copied from the source systems into the hub. In a ‘Registry Hub’, only key identifiers are copied into the hub. Businesses can use a hybrid model, giving data owners the ability to fine-tune how much transactional data is copied into the hub, in what format and where from.

2. Data integration

It’s imperative that a business can dynamically synchronise data into and out of its central hub through a number of data interfaces. This synchronisation needs to happen in real or near real-time. The purpose of an MDM framework is to constantly offer a singular source of ‘truth’ (when it comes to serialisation, there will be billions of ‘singular truths’) on products at a granular level. Having out of date information in an internal hub and transmitted to the EU hub undermines the regulatory effect of FMD. Insights should also be fed back into the source system in order to identify any inconsistencies.

Finally, it’s vital to build in capability to communicate with and manage data from third-parties as any changes that occur in between manufacture and dispense must be captured and potentially recommunicated if they alter the master data in any way.

3. Data integrity and quality capabilities

If a company doesn’t already have data integrity practices in place, data profiling will reveal that information invariably starts off with a fairly low level of data quality. Implementing a data quality tool that standardises, corrects information and completes, (or alerts to) missing information at the point of creation is essential. Good data integrity practices underpin the overall success of MDM implementation.

4. Data governance

Projects that fundamentally shift a business’ operational practices and affect every department in some way require buy-in and involvement at board level, as well as a cross-functional data governance group to own data, support training, continuously monitor processes and resolve any issues. Businesses need to develop processes and ensure that every person through their entire supply chain understand their role.

Creating additional value with MDM

For businesses that are sceptical of implementing an MDM framework, or that already have an alternative plan for creating and sending master data to the EU Hub,it is important to remember that there are significant advantages beyond compliance with FMD regulations that can only be realised if underpinned by a robust MDM strategy.

Understanding in near to real time where products are being dispensed can help businesses direct educational and promotional resources to both healthcare professionals and the end user. Such supply chain visibility can also markedly improve the management of product returns or recalls.

Supply chain data, as and when it is gathered through risk-based verification, can feed into the management of the partnership between manufacturers and any third-party wholesalers and distributors. Aggregation is currently not mandated by the FMD regulation, nor is it supported by the repositories system; however, many businesses in the supply chain require these capabilities as part of their operations. Implementing an MDM framework that can seamlessly manage the data changes that occur when working with these partners is a more resource-efficient practice than using independent systems.

Final thought

An MDM framework offers the most streamlined, resource efficient means of meeting the FMD requirements when it comes to master data. In much the same way as serialisation has presented an investment stumbling block for companies, MDM will be perceived by many as simply too expensive and difficult to achieve. Many businesses lack the internal resources or expertise to implement an MDM framework; however third-party providers are already delivering solutions to support the next phase in master data management.

Master data management for serialisation will also be discussed at FutureLink Munich, which will take place 5–7June 2018. The event will see leaders from across the pharmaceutical and healthcare industries gather to discuss regulatory compliance and shaping the future of digital drug supply with information sharing networks.